Publications by authors named "Karine Baumstarck"

150 Publications

A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory deficit.

BMC Pediatr 2021 Sep 13;21(1):402. Epub 2021 Sep 13.

CEReSS - Health Service Research and Quality of Life Center, Faculty of Medicine, Aix-Marseille University, 27 Bd Jean Moulin, 13385, Marseille, cedex 05, France.

Background: Very preterm children generally perform poorly in executive functions and particularly in working memory. Adaptive training tasks encouraging these children to work continuously on their personal working memory capacity can be very useful. Above all in preschool-age children, several cognitive training programs focused on improving working memory capacity. Cogmed is a computerized visuospatial cognitive training program that improves working memory in children and adolescents with attention-deficit/hyperactivity disorder. The main objective is to assess the long-term effects (18 months) of cognitive training (Cogmed) on visuospatial processing in preschool-age very preterm children with working memory impairment.

Methods: The EPIREMED study is a prospective, randomized, controlled, multicentric trial nested in a population based epidemiological survey. An intervention group (Cogmed cognitive training) and a control group (standard care management) will compare children aged 5½ to 6 years, born between 24- and 34-weeks' gestational age, with a global intelligence quotient > 70 and a working memory index < 85. The study will include 166 children from national study EPIPAGE-2 (Epidemiological Study on Small Gestational Ages). The intervention consists of 25 sessions administered over a 5- to 8-week period. The primary endpoint will be the visuospatial processing, assessed by the score of the visuospatial index: score of the WPPSI-IV (Wechsler Preschool and Primary Scale of Intelligence). The secondary endpoints will allow to assess the executive functions, language and abilities, infant behavior, quality of life assessment, school performance and parental anxiety.

Discussion: This project's primary goal is to demonstrate the necessity of early visuospatial memory assessment within the vulnerable population of very preterm children, and to prove the feasibility and efficacy of computerized cognitive training using online software programs. A better global neuropsychological development improvement (visuospatial processing and other far transfer) can be expected with an improvement in learning and decreased behavioral problems. In the long term, these improvements might also reduce those global costs linked to the consequences of extreme prematurity.

Trial Registration: NCT02757794 (registered on 2nd May 2016 at ClinicalTrial.gov).
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http://dx.doi.org/10.1186/s12887-021-02867-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8436542PMC
September 2021

Mortality among inpatients with bipolar disorders and COVID-19: a propensity score matching analysis in a national French cohort study.

Psychol Med 2021 Aug 24:1-10. Epub 2021 Aug 24.

CEReSS-Health Service Research and Quality of Life Center, Aix-Marseille University, 27 Boulevard Jean Moulin, Marseille13005, France.

Background: It remains unknown whether coronavirus disease 2019 (COVID-19) patients with bipolar disorders (BDs) are at an increased risk of mortality. We aimed to establish whether health outcomes and care differed between patients infected with COVID-19 with BD and patients without a diagnosis of severe mental illness.

Methods: We conducted a population-based cohort study of all patients with identified COVID-19 and respiratory symptoms who were hospitalized in France between February and June 2020. The outcomes were in-hospital mortality and intensive care unit (ICU) admission. We used propensity score matching to control for confounding factors.

Results: In total, 50 407 patients were included, of whom 480 were patients with BD. Patients with BD were 2 years older, more frequently women and had more comorbidities than controls without a diagnosis of severe mental illness. Patients with BD had an increased in-hospital mortality rate (26.6% v. 21.9%; p = 0.034) and similar ICU admission rate (27.9% v. 28.4%, p = 0.799), as confirmed by propensity analysis [odds ratio, 95% confidence interval (OR, 95% CI) for mortality: 1.30 (1.16-1.45), p < 0.0001]. Significant interactions between BD and age and between BD and social deprivation were found, highlighting that the most important inequalities in mortality were observed in the youngest [OR, 95% CI 2.28 (1.18-4.41), p = 0.0015] and most deprived patients with BD [OR, 95% CI 1.60 (1.33-1.92), p < 0.001].

Conclusions: COVID-19 patients with BD were at an increased risk of mortality, which was exacerbated in the youngest and most deprived patients with BD. Patients with BD should thus be targeted as a high-risk population for severe forms of COVID-19, requiring enhanced preventive and disease management strategies.
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http://dx.doi.org/10.1017/S0033291721003676DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8438351PMC
August 2021

Quality of life of transplanted children and their parents: a cross-sectional study.

Orphanet J Rare Dis 2021 Aug 17;16(1):364. Epub 2021 Aug 17.

EA 3279 CEReSS - Health Service Research and Quality of Life Center, Aix-Marseille Univ, 27 bd Jean Moulin, 13385, Marseille Cedex 05, France.

Background: Transplantation is a saving therapeutic that has heavy consequences. The quality of life (QoL) of transplanted children and their parents has been little studied and should help physicians better manage these patients. The objectives of the study were to assess: (1) the QoL of transplanted children and parents and compare it with that of children with other chronic conditions associated with long-term consequences, and (2) potential variables modulating the QoL.

Methods: This cross-sectional study was performed in a multidisciplinary paediatric unit (Timone Hospital, Marseille, France). Children were less than 18 years old; had a liver, kidney or heart transplant; and had a time since transplantation of 1-10 years. Socio-demographics and clinical data were recorded from medical forms. The QoL was assessed using the VSP-A (Vécu et Santé Perçue de l'Adolescent et de l'Enfant) and the WhoQoL self-reported questionnaires.

Results: Forty-five families were included (response rate: 76%). The transplanted organs were the liver for 20 children, the kidney for 15 children, and the heart for 10 children. The QoL of transplanted children reported by their parents was better than that of children with inborn errors of metabolism and similar to that of childhood leukaemia survivors. The QoL of parents of transplanted children was better than that of parents of children with inborn errors of metabolism and did not differ from French norms. The QoL did not differ according to the nature of the transplanted organ, sex or the main sociodemographic data. The main modulators decreasing QoL were residual treatment level, medications switch and the presence of another regular treatment.

Conclusion: Transplanted children and their families reported a fairly preserved QoL compared to children with other chronic health conditions. Special attention should be given to QoL modulators related to therapeutic management (medication switches, regular treatments) that might be amenable to improve the QoL. Trial registration Ethics committee of Aix-Marseille University, France (reference number: 2014-08-04-03, 24/4/2015; https://www.univ-amu.fr/fr/public/comite-dethique ).
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http://dx.doi.org/10.1186/s13023-021-01987-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8369793PMC
August 2021

Association between mortality and highly antimicrobial-resistant bacteria in intensive care unit-acquired pneumonia.

Sci Rep 2021 Aug 13;11(1):16497. Epub 2021 Aug 13.

Department of Anesthesiology and Intensive Care Unit, Aix Marseille University, Assistance Publique Hôpitaux Universitaires de Marseille, Nord Hospital, Marseille, France.

Data on the relationship between antimicrobial resistance and mortality remain scarce, and this relationship needs to be investigated in intensive care units (ICUs). The aim of this study was to compare the ICU mortality rates between patients with ICU-acquired pneumonia due to highly antimicrobial-resistant (HAMR) bacteria and those with ICU-acquired pneumonia due to non-HAMR bacteria. We conducted a multicenter, retrospective cohort study using the French National Surveillance Network for Healthcare Associated Infection in ICUs ("REA-Raisin") database, gathering data from 200 ICUs from January 2007 to December 2016. We assessed all adult patients who were hospitalized for at least 48 h and presented with ICU-acquired pneumonia caused by S. aureus, Enterobacteriaceae, P. aeruginosa, or A. baumannii. The association between pneumonia caused by HAMR bacteria and ICU mortality was analyzed using the whole sample and using a 1:2 matched sample. Among the 18,497 patients with at least one documented case of ICU-acquired pneumonia caused by S. aureus, Enterobacteriaceae, P. aeruginosa, or A. baumannii, 3081 (16.4%) had HAMR bacteria. The HAMR group was associated with increased ICU mortality (40.3% vs. 30%, odds ratio (OR) 95%, CI 1.57 [1.45-1.70], P < 0.001). This association was confirmed in the matched sample (3006 HAMR and 5640 non-HAMR, OR 95%, CI 1.39 [1.27-1.52], P < 0.001) and after adjusting for confounding factors (OR ranged from 1.34 to 1.39, all P < 0.001). Our findings suggest that ICU-acquired pneumonia due to HAMR bacteria is associated with an increased ICU mortality rate, ICU length of stay, and mechanical ventilation duration.
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http://dx.doi.org/10.1038/s41598-021-95852-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8363636PMC
August 2021

Association Between Mental Health Disorders and Mortality Among Patients With COVID-19 in 7 Countries: A Systematic Review and Meta-analysis.

JAMA Psychiatry 2021 Jul 27. Epub 2021 Jul 27.

Aix-Marseille University, CEReSS-Health Service Research and Quality of Life Center, Marseille, France.

Importance: Heterogeneous evidence exists for the association between COVID-19 and the clinical outcomes of patients with mental health disorders. It remains unknown whether patients with COVID-19 and mental health disorders are at increased risk of mortality and should thus be targeted as a high-risk population for severe forms of COVID-19.

Objective: To determine whether patients with mental health disorders were at increased risk of COVID-19 mortality compared with patients without mental health disorders.

Data Sources: For this systematic review and meta-analysis, MEDLINE, Web of Science, and Google Scholar were searched from inception to February 12, 2021. Bibliographies were also searched, and the corresponding authors were directly contacted. The search paradigm was based on the following combination: (mental, major[MeSH terms]) AND (COVID-19 mortality[MeSH terms]). To ensure exhaustivity, the term mental was replaced by psychiatric, schizophrenia, psychotic, bipolar disorder, mood disorders, major depressive disorder, anxiety disorder, personality disorder, eating disorder, alcohol abuse, alcohol misuse, substance abuse, and substance misuse.

Study Selection: Eligible studies were population-based cohort studies of all patients with identified COVID-19 exploring the association between mental health disorders and mortality.

Data Extraction And Synthesis: Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline was used for abstracting data and assessing data quality and validity. This systematic review is registered with PROSPERO.

Main Outcomes And Measures: Pooled crude and adjusted odds ratios (ORs) for the association of mental health disorders with mortality were calculated using a 3-level random-effects (study/country) approach with a hierarchical structure to assess effect size dependency.

Results: In total, 16 population-based cohort studies (data from medico-administrative health or electronic/medical records databases) across 7 countries (1 from Denmark, 2 from France, 1 from Israel, 3 from South Korea, 1 from Spain, 1 from the UK, and 7 from the US) and 19 086 patients with mental health disorders were included. The studies covered December 2019 to July 2020, were of good quality, and no publication bias was identified. COVID-19 mortality was associated with an increased risk among patients with mental health disorders compared with patients without mental health disorders according to both pooled crude OR (1.75 [95% CI, 1.40-2.20]; P < .05) and adjusted OR (1.38 [95% CI, 1.15-1.65]; P < .05). The patients with severe mental health disorders had the highest ORs for risk of mortality (crude OR: 2.26 [95% CI, 1.18-4.31]; adjusted OR: 1.67 [95% CI, 1.02-2.73]).

Conclusions And Relevance: In this systematic review and meta-analysis of 16 observational studies in 7 countries, mental health disorders were associated with increased COVID-19-related mortality. Thus, patients with mental health disorders should have been targeted as a high-risk population for severe forms of COVID-19, requiring enhanced preventive and disease management strategies. Future studies should more accurately evaluate the risk for patients with each mental health disorder. However, the highest risk seemed to be found in studies including individuals with schizophrenia and/or bipolar disorders.
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http://dx.doi.org/10.1001/jamapsychiatry.2021.2274DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8317055PMC
July 2021

Prophylactic manual rotation of occiput posterior and transverse positions to decrease operative delivery: the PROPOP randomized clinical trial.

Am J Obstet Gynecol 2021 May 24. Epub 2021 May 24.

Department of Obstetrics and Gynecology, Nord Hospital, Assistance Publique - Hopitaux de Marseille, Chemin des Bourrely, Marseille, France; CEReSS, Health Service Research and Quality of Life Center, Aix-Marseille University, Marseille, France; Department of Obstetrics and Gynecology, Saint Joseph Hospital, Marseille, France.

Background: Persistent occiput posterior and occiput transverse positions are the most common malpositions of the fetal head during labor and are associated with prolonged second stage of labor, cesarean deliveries, instrumental deliveries, severe perineal tears, postpartum hemorrhage, and chorioamnionitis. Manual rotation is one of several strategies described to deal with these malpositions.

Objective: This study aimed to determine if the trial of prophylactic manual rotation at the early second stage of labor is associated with a decrease in operative deliveries (instrumental and/or cesarean deliveries).

Study Design: We conducted a multicenter, open-label, randomized controlled trial in 4 French hospitals. Women with singleton term pregnancy and occiput posterior or occiput transverse position confirmed by ultrasound at the early second stage of labor and with epidural analgesia were eligible. Women were randomly assigned (1:1) to either undergo a trial of prophylactic manual rotation of occiput posterior or occiput transverse position (intervention group) or no trial of prophylactic manual rotation (standard group). The primary outcome was operative delivery (instrumental and/or cesarean deliveries). The secondary outcomes were length of the second stage of labor, maternal complications (postpartum hemorrhage, operative complications during cesarean delivery, episiotomy and perineal tears), and neonatal complications (Apgar score of <5 at 10 minutes, arterial umbilical pH of <7.10, neonatal injuries, neonatal intensive care unit admission). The main analysis was focused on intention-to-treat analysis.

Results: From December 2015 to December 2019, a total of 257 women (mean age, 30.4 years; mean gestational age, 40.1 weeks) were randomized: 126 were assigned to the intervention group and 131 were assigned to the standard group. Operative delivery was significantly less frequent in the intervention group compared with the standard group (29.4% [37 of 126] vs 41.2% [54 of 131]; P=.047; differential [intervention-standard] [95% confidence interval] = -11.8 [-15.7 to -7.9]; unadjusted odds ratio [95% confidence interval] = 0.593 [0.353-0.995]). Women in the intervention group were more likely to have a significantly shorter second stage of labor.

Conclusion: Trial of prophylactic manual rotation of occiput posterior or occiput transverse positions during the early second stage of labor was statistically associated with a reduced risk of operative delivery. This maneuver could be a safe strategy to prevention operative delivery.
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http://dx.doi.org/10.1016/j.ajog.2021.05.020DOI Listing
May 2021

End of life breast cancer care in women with severe mental illnesses.

Sci Rep 2021 May 13;11(1):10167. Epub 2021 May 13.

Faculté de Médecine - Secteur Timone, EA 3279: CEReSS -Centre d'Etude et de Recherche sur les Services de Santé et la Qualité de vie, Aix-Marseille Univ., 27 Boulevard Jean Moulin, 13005, Marseille, France.

Little is known on the end-of-life (EOL) care of terminal breast cancer in women with severe psychiatric disorder (SPD). The objective was to determine if women with SPD and terminal breast cancer received the same palliative and high-intensity care during their end-of-life than women without SPD. Study design, setting, participants. This population-based cohort study included all women aged 15 and older who died from breast cancer in hospitals in France (2014-2018). Key measurements/outcomes. Indicators of palliative care and high-intensity EOL care. Multivariable models were performed, adjusted for age at death, year of death, social deprivation, duration between cancer diagnosis and death, metastases, comorbidity, smoking addiction and hospital category. The analysis included 1742 women with SPD (287 with bipolar disorder, 1075 with major depression and 380 with schizophrenia) and 36,870 women without SPD. In multivariate analyses, women with SPD had more palliative care (adjusted odd ratio aOR 1.320, 95%CI [1.153-1.511], p < 0.001), longer palliative care follow-up before death (adjusted beta = 1.456, 95%CI (1.357-1.555), p < 0.001), less chemotherapy, surgery, imaging/endoscopy, and admission in emergency department and intensive care unit. Among women with SPD, women with bipolar disorders and schizophrenia died 5 years younger than those with recurrent major depression. The survival time was also shortened in women with schizophrenia. Despite more palliative care and less high-intensity care in women with SPD, our findings also suggest the existence of health disparities in women with bipolar disorders and schizophrenia compared to women with recurrent major depression and without SPD. Targeted interventions may be needed for women with bipolar disorders and schizophrenia to prevent these health disparities.
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http://dx.doi.org/10.1038/s41598-021-89726-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8119688PMC
May 2021

Pain Associated With Cervical Priming for First-Trimester Surgical Abortion: A Randomized Controlled Trial.

Obstet Gynecol 2021 06;137(6):1055-1060

Service de Gynecologie Obstetrique, Hôpital La Conception, and APHM, Hôpital de la Timone, Service Biostatistique et Technologies de l'Information et de la Communication, Marseille, France.

Objective: To compare the effect of cervical priming with mifepristone with that of misoprostol on pain perception during surgical induced abortion under paracervical block.

Methods: We conducted a randomized, single-blind, two-center study of women undergoing surgical induced abortion at less than 14 weeks of gestation under paracervical block. Participants were randomized to receive cervical priming with 200 mg of oral mifepristone 36 hours or 400 micrograms buccal misoprostol 3 hours before surgery. The primary outcome was pain during mechanical cervical dilation evaluated by a 100-mm visual analog scale (VAS). Secondary outcomes were pain during aspiration, preoperative and postoperative pain, participant satisfaction, duration of the procedure, occurrence of complications, and ease of performing the procedure (assessed by a 100-mm VAS). We estimated that 110 women would have to be included to have 90% power to detect a 13mm-difference of VAS for pain.

Results: Between June 2017 and May 2019, 314 women were eligible and 110 were randomized (55 in each group). Patient characteristics were similar in the two groups. The mean VAS score during mechanical cervical dilation was lower in the mifepristone group (35.6±21 vs 43.5±21, P=.04) as was the mean VAS during aspiration (34±24 vs 47.8±23, P=.003). The preoperative and postoperative mean VAS, satisfaction and duration of procedures were similar between groups. The procedure was significantly easier to perform in the mifepristone group (88±16 vs 80±23, P=.004).

Conclusion: Cervical priming with mifepristone for surgical induced abortion under paracervical block up to 14 weeks of gestation is more effective than misoprostol in reducing pain perception.

Clinical Trial Registration: ClinicalTrials.gov, NCT03043014.
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http://dx.doi.org/10.1097/AOG.0000000000004376DOI Listing
June 2021

Does faecal calprotectin increase may be linked to lactose intolerance in patients with irritable bowel syndrome?

Minerva Gastroenterol (Torino) 2021 Apr 8. Epub 2021 Apr 8.

Gastroenterology Unit, North Hospital, Assistance Publique-Hôpitaux de Marseille, Aix-Marseille Université, Marseille, France.

Background: Irritable bowel syndrome (IBS) is a multifactorial condition without any specific investigation. Faecal calprotectin (FC) may be elevated in IBS without any explanation. In addition, some patients with IBS have symptoms related to lactose intolerance.

Aims: Our main objective was to investigate whether an increase in FC could be related to lactose intolerance in patients with IBS.

Methods: In this retrospective single-center study, all patients with IBS who have underwent a FC test and a lactose respiratory test within a period of less than 6 months were eligible. A FC greater than or equal to 50 μg/g was considered abnormal.

Results: 76 patients (48 females), mean age 38±15 years were included. Symptoms were respectively: bloating in 57%, diarrhea in 76% and abdominal pain in 46% of cases. Among the 76 patients: 22 (29%) had FC ≥ 50 μg/g and 9/22 (41%) had a positive lactose test. No significant relationship could be identified between the increase in FC and the lactose test positivity. The value of the FC was also not related to the subtype of IBS or the positivity of the glucose test.

Conclusions: In our study, the increase in FC was not significantly related to the presence of lactose intolerance. Nevertheless, our work, despite its originality, is limited by its retrospective nature and small number of patients. Future studies including larger numbers of patients may identify the causes of elevated FC in patients with IBS to individualize different subgroups of patients to best adapt therapeutic management.
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http://dx.doi.org/10.23736/S2724-5985.21.02802-6DOI Listing
April 2021

Oesophageal pressure as a surrogate of pleural pressure in mechanically ventilated patients.

ERJ Open Res 2021 Jan 8;7(1). Epub 2021 Mar 8.

Médecine Intensive Réanimation, Hôpital Nord, AP-HM, Marseille, France.

Background: Oesophageal pressure ( ) is used to approximate pleural pressure ( ) and therefore to estimate transpulmonary pressure ( ). We aimed to compare oesophageal and regional pleural pressures and to calculate transpulmonary pressures in a prospective physiological study on lung transplant recipients during their stay in the intensive care unit of a tertiary university hospital.

Methods: Lung transplant recipients receiving invasive mechanical ventilation and monitored by oesophageal manometry and dependent and nondependent pleural catheters were investigated during the post-operative period. We performed simultaneous short-time measurements and recordings of oesophageal manometry and pleural pressures. Expiratory and inspiratory were computed by subtracting regional or from airway pressure; inspiratory was also calculated with the elastance ratio method.

Results: 16 patients were included. Among them, 14 were analysed. Oesophageal pressures correlated with dependent and nondependent pleural pressures during expiration (R=0.71, p=0.005 and R=0.77, p=0.001, respectively) and during inspiration (R=0.66 for both, p=0.01 and p=0.014, respectively). values calculated using were close to those obtained from the dependent pleural catheter but higher than those obtained from the nondependent pleural catheter both during expiration and inspiration.

Conclusions: In ventilated lung transplant recipients, oesophageal manometry is well correlated with pleural pressure. The absolute value of is higher than of nondependent lung regions and could therefore underestimate the highest level of lung stress in those at high risk of overinflation.
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http://dx.doi.org/10.1183/23120541.00646-2020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938048PMC
January 2021

Compliance with Early Long-Term Prophylaxis Guidelines for Severe Hemophilia A.

J Pediatr 2021 Jul 4;234:212-219.e3. Epub 2021 Mar 4.

APHM, La Timone Children's Hospital, Department of Pediatric Hematology, Immunology and Oncology, Marseille, France; Aix Marseille Univ, INSERM, INRAe, C2VN, Marseille, France.

Objectives: To evaluate the applicability and compliance with guidelines for early initiation of long-term prophylaxis in infants with severe hemophilia A and to identify factors associated with guideline compliance.

Study Design: This real-world, prospective, multicenter, population-based FranceCoag study included almost all French boys with severe hemophilia A, born between 2000 and 2009 (ie, after guideline implementation).

Results: We included 333 boys in the study cohort. The cumulative incidence of long-term prophylaxis use was 61.2% at 3 years of age vs 9.5% in a historical cohort of 39 boys born in 1996 (ie, before guideline implementation). The guidelines were not applicable in 23.1% of patients due to an early intracranial bleeding or inhibitor development. Long-term prophylaxis was delayed in 10.8% of patients. In the multivariate analysis, 2 variables were significantly associated with "timely long-term prophylaxis" as compared with "delayed long-term prophylaxis": hemophilia treating center location in the southern regions of France (OR 23.6, 95% CI 1.9-286.7, P = .013 vs Paris area) and older age at long-term prophylaxis indication (OR 7.2 for each additional year, 95% CI 1.2-43.2, P = .031). Long-term prophylaxis anticipation was observed in 39.0% of patients. Earlier birth year (OR 0.5, 95% CI 0.3-0.8, P = .010 for birth years 2005-2009 vs 2000-2004) and age at first factor replacement (OR 1.9 for each additional year, 95% CI 1.2-3.0, P = .005) were significantly associated with "long-term prophylaxis guideline compliance" vs "long-term prophylaxis anticipation."

Conclusions: This study suggests that long-term prophylaxis guidelines are associated with increased long-term prophylaxis use. However, early initiation of long-term prophylaxis remains a challenge.
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http://dx.doi.org/10.1016/j.jpeds.2021.02.071DOI Listing
July 2021

Preemptive ganciclovir for mechanically ventilated patients with cytomegalovirus reactivation.

Ann Intensive Care 2021 Feb 11;11(1):33. Epub 2021 Feb 11.

Sorbonne Université, INSERM, Médecine Intensive Réanimation, Institut de Cardiologie, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.

Background: The effect of cytomegalovirus (CMV) reactivation on the length of mechanical ventilation and mortality in immunocompetent ICU patients requiring invasive mechanical ventilation remains controversial. The main objective of this study was to determine whether preemptive intravenous ganciclovir increases the number of ventilator-free days in patients with CMV blood reactivation.

Methods: This double-blind, placebo-controlled, randomized clinical trial involved 19 ICUs in France. Seventy-six adults ≥ 18 years old who had been mechanically ventilated for at least 96 h, expected to remain on mechanical ventilation for ≥ 48 h, and exhibited reactivation of CMV in blood were enrolled between February 5th, 2014, and January 23rd, 2019. Participants were randomized to receive ganciclovir 5 mg/kg bid for 14 days (n = 39) or a matching placebo (n = 37).

Results: The primary endpoint was ventilator-free days from randomization to day 60. Prespecified secondary outcomes included day 60 mortality. The trial was stopped for futility based on the results of an interim analysis by the DSMB. The subdistribution hazard ratio for being alive and weaned from mechanical ventilation at day 60 for patients receiving ganciclovir (N = 39) compared with control patients (N = 37) was 1.14 (95% CI from 0.63 to 2.06; P = 0.66). The median [IQR] numbers of ventilator-free days for ganciclovir-treated patients and controls were 10 [0-51] and 0 [0-43] days, respectively (P = 0.46). Mortality at day 60 was 41% in patients in the ganciclovir group and 43% in the placebo group (P = .845). Creatinine levels and blood cells counts did not differ significantly between the two groups.

Conclusions: In patients mechanically ventilated for ≥ 96 h with CMV reactivation in blood, preemptive ganciclovir did not improve the outcome.
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http://dx.doi.org/10.1186/s13613-020-00793-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876264PMC
February 2021

Bedside POCUS during ward emergencies is associated with improved diagnosis and outcome: an observational, prospective, controlled study.

Crit Care 2021 01 22;25(1):34. Epub 2021 Jan 22.

Assistance Publique Hôpitaux de Marseille, Department of Anesthesiology and Intensive Care, Hôpital Nord, Aix Marseille University, 13015, Marseille, France.

Background: Rapid response teams are intended to improve early diagnosis and intervention in ward patients who develop acute respiratory or circulatory failure. A management protocol including the use of a handheld ultrasound device for immediate point-of-care ultrasound (POCUS) examination at the bedside may improve team performance. The main objective of the study was to assess the impact of implementing such a POCUS-guided management on the proportion of adequate immediate diagnoses in two groups. Secondary endpoints included time to treatment and patient outcomes.

Methods: A prospective, observational, controlled study was conducted in a single university hospital. Two teams alternated every other day for managing in-hospital ward patients developing acute respiratory and/or circulatory failures. Only one of the team used an ultrasound device (POCUS group).

Results: We included 165 patients (POCUS group 83, control group 82). Proportion of adequate immediate diagnoses was 94% in the POCUS group and 80% in the control group (p = 0.009). Time to first treatment/intervention was shorter in the POCUS group (15 [10-25] min vs. 34 [15-40] min, p < 0.001). In-hospital mortality rates were 17% in the POCUS group and 35% in the control group (p = 0.007), but this difference was not confirmed in the propensity score sample (29% vs. 34%, p = 0.53).

Conclusion: Our study suggests that protocolized use of a handheld POCUS device at the bedside in the ward may improve the proportion of adequate diagnosis, the time to initial treatment and perhaps also survival of ward patients developing acute respiratory or circulatory failure. Clinical Trial Registration NCT02967809. Registered 18 November 2016, https://clinicaltrials.gov/ct2/show/NCT02967809 .
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http://dx.doi.org/10.1186/s13054-021-03466-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7825196PMC
January 2021

Acceptability of a Novel Telemedication Review for Older Adults in Nursing Homes in France: A Qualitative Study.

Clin Interv Aging 2021 7;16:19-34. Epub 2021 Jan 7.

ORS PACA, Southeastern Health Regional Observatory, Marseille, France.

Purpose: In France, polypharmacy among older people living in nursing homes (NH) is a major public health concern. In this context, the randomized controlled trial TEM-EHPAD was recently launched in various NH in southern France to evaluate the impact of implementing a novel telemedication review (TMR) on hospital admission rates of NH residents at high risk of iatrogenic disease. A qualitative study was integrated into the main trial study to assess general practitioners' (GP) and other NH healthcare professionals' (HP) acceptability of the proposed TMR before its implementation.

Material And Methods: A qualitative study using face-to-face semi-structured interviews was conducted with 16 HP before the beginning of the intervention. A manual thematic analysis was performed on the transcribed interviews.

Results: Four main themes emerged from the thematic analysis: HP perceptions of the TMR, difficulties related to medication management for NH residents, HP perceptions of the roles of different professionals, and facilitators of good practices. Most participants were favorable to the TMR, but some GP expressed fears about loss of control over their prescription writing.

Conclusion: This study fulfilled its objective to assess pre-intervention acceptability by GP and other HP. Results provided important information about how to adapt the TMR intervention to make it more acceptable to HP who will be involved in TEM-EHPAD. One of the main recommendations is the importance of providing participating GP with the opportunity to take part in the process of reviewing prescriptions.
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http://dx.doi.org/10.2147/CIA.S283496DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7800438PMC
April 2021

Assessing the experience of the quality of care of patients living with multiple sclerosis and their caregivers: The MusiCare questionnaire.

Eur J Neurol 2021 03 5;28(3):910-920. Epub 2021 Jan 5.

Public Health: Quality of Life and Chronic Diseases EA3279, Aix-Marseille University, Marseille, France.

Background And Purpose: Patients with a chronic illness, such as multiple sclerosis (MS), and their natural caregivers have a specific experience of healthcare and health services. These experiences need to be assessed to evaluate the quality of care. Our objective was to develop a French-language questionnaire to evaluate the quality of care as experienced by MS patients and their natural caregivers.

Methods: Eligible patients had been diagnosed with MS according to the McDonald criteria. Eligible caregivers were individuals designated by the patients. The MusiCare questionnaire was developed in two standard phases: (i) item generation, based on interviews with patients and caregivers; and (ii) validation, consisting of validity, reliability, external validity, reproducibility, and responsiveness measures.

Results: In total, 1088 patients (n = 660) and caregivers (n = 488) were recruited. The initial 64-item version of MusiCare was administered to a random subsample (n = 748). The validation process generated a 35-item questionnaire. Internal consistency and scalability were satisfactory. Testing of the external validity revealed expected associations between MusiCare scores and sociodemographic and clinical data. The questionnaire showed good reproducibility and responsiveness.

Conclusions: The availability of a reliable and validated French-language self-report questionnaire probing the experience of the quality of care for MS will allow the feedback of patients and caregivers to be incorporated into a continuous healthcare quality-improvement strategy.
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http://dx.doi.org/10.1111/ene.14685DOI Listing
March 2021

Risk factors and events in the adult intensive care unit associated with pain as self-reported at the end of the intensive care unit stay.

Crit Care 2020 12 7;24(1):685. Epub 2020 Dec 7.

Unité de recherche EA3279, Aix-Marseille Université, Marseille, France.

Background: The short-term and long-term consequences of the most frequent painful procedures performed in the ICU are unclear. This study aimed to identify the risk factors associated with pain-related discomfort perceived by critically ill patients during the whole ICU stay as self-reported by patients at the end of their ICU stay.

Methods: The study involved 34 ICUs. Adult patients who survived an ICU stay of 3 calendar days or more were eligible for inclusion. Discomforts, including the pain-related discomfort, were assessed using the French 18-item questionnaire on discomfort in ICU patients, the "Inconforts des Patients de REAnimation" (IPREA). Patients scored each item from 0 (minimal discomfort) to 10 (maximal discomfort). Associations between patient characteristics at ICU admission, life support therapies and main potentially painful procedures performed during the ICU stay and pain-related discomfort scores assessed at the end of the ICU stay were analyzed.

Results: Patients with complete IPREA questionnaires (n = 2130) were included. The median pain-related discomfort score was 3 (IQR 0-5). From the univariate analysis, pain-related discomfort scores were negatively correlated with age and positively correlated with ICU stay duration; surgical patients reported significant higher pain-related discomfort scores than medical patients; chest drain insertion, chest drain removal, use of bladder catheter, central venous catheter (CVC) insertion, complex dressing change, and intra-hospital transport were associated with pain-related discomfort scores. From the multivariate analyses using generalized estimating equations models, only age, chest drain removal, use of a bladder catheter, CVC insertion, and intra-hospital transport were the main risk factors associated with pain-related discomfort scores.

Conclusion: Patients who underwent chest drain removal, bladder catheter, CVC insertion, and intra-hospital transport during their ICU stay reported higher pain-related discomfort scores (with respect to the whole ICU stay and assessed at the end of their ICU stay) than patients who did not experience these events. This study may pave the way for further targeted studies aiming at investigating a causal link between these common procedures in the ICU and adult critically ill patients' perceptions of their ICU stay regarding recalled pain.

Trial Registration: Clinicaltrials.gov Identifier NCT02442934, retrospectively registered on May 13, 2015.
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http://dx.doi.org/10.1186/s13054-020-03396-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7722444PMC
December 2020

Measuring the Patient Experience of Mental Health Care: A Systematic and Critical Review of Patient-Reported Experience Measures.

Patient Prefer Adherence 2020 3;14:2147-2161. Epub 2020 Nov 3.

Aix-Marseille University, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, France.

Background: There is growing concern about measuring patient experience with mental health care. There are currently numerous patient-reported experience measures (PREMs) available for mental health care, but there is little guidance for selecting the most suitable instruments. The objective of this systematic review was to provide an overview of the psychometric properties and the content of available PREMs.

Methods: A comprehensive review following the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines was conducted using the MEDLINE database with no date restrictions. The content of PREMs was analyzed using an inductive qualitative approach, and the methodological quality was assessed according to Pesudovs quality criteria.

Results: A total of 86 articles examining 75 PREMs and totaling 1932 items were included. Only four PREMs used statistical methods from item response theory (IRT). The 1932 items covered seven key mental health care domains: interpersonal relationships (22.6%), followed by respect and dignity (19.3%), access and care coordination (14.9%), drug therapy (14.1%), information (9.6%), psychological care (6.8%) and care environment (6.1%). Additionally, a few items focused on patient satisfaction (6.7%) rather than patient experience. No instrument covered the latent trait continuum of patient experience, as defined by the inductive qualitative approach, and the psychometric properties of the instruments were heterogeneous.

Conclusion: This work is a critical step in the creation of an item library to measure mental health care patient-reported experience that will be used in France to develop, validate, and standardize item banks and computerized adaptive testing (CAT) based on IRT. It will also provide internationally replicable measures that will allow direct comparisons of mental health care systems.

Trial Registration: NCT02491866.
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http://dx.doi.org/10.2147/PPA.S255264DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7653683PMC
November 2020

Disparities in Intensive Care Unit Admission and Mortality Among Patients With Schizophrenia and COVID-19: A National Cohort Study.

Schizophr Bull 2021 04;47(3):624-634

FondaMental Academic Centers of Expertise for Schizophrenia, Créteil, France.

Patients with schizophrenia (SCZ) represent a vulnerable population who have been understudied in COVID-19 research. We aimed to establish whether health outcomes and care differed between patients with SCZ and patients without a diagnosis of severe mental illness. We conducted a population-based cohort study of all patients with identified COVID-19 and respiratory symptoms who were hospitalized in France between February and June 2020. Cases were patients who had a diagnosis of SCZ. Controls were patients who did not have a diagnosis of severe mental illness. The outcomes were in-hospital mortality and intensive care unit (ICU) admission. A total of 50 750 patients were included, of whom 823 were SCZ patients (1.6%). The SCZ patients had an increased in-hospital mortality (25.6% vs 21.7%; adjusted OR 1.30 [95% CI, 1.08-1.56], P = .0093) and a decreased ICU admission rate (23.7% vs 28.4%; adjusted OR, 0.75 [95% CI, 0.62-0.91], P = .0062) compared with controls. Significant interactions between SCZ and age for mortality and ICU admission were observed (P = .0006 and P < .0001). SCZ patients between 65 and 80 years had a significantly higher risk of death than controls of the same age (+7.89%). SCZ patients younger than 55 years had more ICU admissions (+13.93%) and SCZ patients between 65 and 80 years and older than 80 years had less ICU admissions than controls of the same age (-15.44% and -5.93%, respectively). Our findings report the existence of disparities in health and health care between SCZ patients and patients without a diagnosis of severe mental illness. These disparities differed according to the age and clinical profile of SCZ patients, suggesting the importance of personalized COVID-19 clinical management and health care strategies before, during, and after hospitalization for reducing health disparities in this vulnerable population.
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http://dx.doi.org/10.1093/schbul/sbaa158DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7665717PMC
April 2021

Risk stratification of adrenal masses by [ F]FDG PET/CT: Changing tactics.

Clin Endocrinol (Oxf) 2021 02 26;94(2):133-140. Epub 2020 Nov 26.

Service de Médecine Nucléaire, Centre Hospitalo-Universitaire de la Timone, APHM, Centre Européen de Recherche en Imagerie Médicale, Aix Marseille Univ, Marseille, France.

Context: [ F]FDG PET/CT improves adrenal tumour characterization. However, there is still no consensus regarding the optimal imaging biomarkers of malignancy.

Objectives: To assess the performance of Tumour standardized uptake value (SUV) :Liver SUV for malignancy-risk and to build and evaluate a prediction model.

Design/methods: The cohort consisted of consecutive patients with adrenal masses evaluated by [ F]FDG PET/CT. The gold standard for malignancy was based on histology or a multidisciplinary consensus in nonoperated cases. The performance of the previously reported cut-off for Tumour SUV :Liver SUV (>1.5) was evaluated in this independent cohort. Additionally, a predictive model of malignancy was built from the training cohort (previous study) and evaluated in the validation cohort (current study).

Results: Sixty-four patients were evaluated; 28% of them had a Cushing's syndrome. Fifty-four adrenal masses were classified as benign and 10 as malignant (including 7 adrenocortical carcinomas). Compared to benign masses, malignant lesions were larger in size, had higher unenhanced densities and higher [ F]FDG uptake. CT-derived anthropometric parameters did not differ between benign and malignant masses. A tumour SUV :Liver SUV  > 1.5 showed a good diagnostic performance: Se = 90.0%/Sp = 92.6%/PPV = 69.2%/NPV = 98.0% and accuracy = 92.2%. A predictive model based on tumour size and tumour-to-liver uptake SUV ratio for malignancy-risk was validated and provides a complementary approach to the ratio.

Conclusions: Tumour SUV :Liver SUV uptake ratio is a useful biomarker for diagnosis of adrenal masses. Another tactic would be to calculate with the model an individual risk of malignancy and integrate this information into a shared decision-making process.
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http://dx.doi.org/10.1111/cen.14338DOI Listing
February 2021

Palliative and high-intensity end-of-life care in schizophrenia patients with lung cancer: results from a French national population-based study.

Eur Arch Psychiatry Clin Neurosci 2020 Sep 2. Epub 2020 Sep 2.

CEReSS-Health Services Research and Quality of Life Center, Faculté de Médecine, Secteur Timone, EA 3279, CEReSS -Centre D'Etude Et de Recherche Sur Les Services de Santé Et La Qualité de Vie, Aix-Marseille University, 27 Boulevard Jean Moulin, 13005, Marseille, France.

Schizophrenia is marked by inequities in cancer treatment and associated with high smoking rates. Lung cancer patients with schizophrenia may thus be at risk of receiving poorer end-of-life care compared to those without mental disorder. The objective was to compare end-of-life care delivered to patients with schizophrenia and lung cancer with patients without severe mental disorder. This population-based cohort study included all patients aged 15 and older who died from their terminal lung cancer in hospital in France (2014-2016). Schizophrenia patients and controls without severe mental disorder were selected and indicators of palliative care and high-intensity end-of-life care were compared. Multivariable generalized log-linear models were performed, adjusted for sex, age, year of death, social deprivation, time between cancer diagnosis and death, metastases, comorbidity, smoking addiction and hospital category. The analysis included 633 schizophrenia patients and 66,469 controls. The schizophrenia patients died 6 years earlier, had almost twice more frequently smoking addiction (38.1%), had more frequently chronic pulmonary disease (32.5%) and a shorter duration from cancer diagnosis to death. In multivariate analysis, they were found to have more and earlier palliative care (adjusted Odds Ratio 1.27 [1.03;1.56]; p = 0.04), and less high-intensity end-of-life care (e.g., chemotherapy 0.53 [0.41;0.70]; p < 0.0001; surgery 0.73 [0.59;0.90]; p < 0.01) than controls. Although the use and/or continuation of high-intensity end-of-life care is less important in schizophrenia patients with lung cancer, some findings suggest a loss of chance. Future studies should explore the expectations of patients with schizophrenia and lung cancer to define the optimal end-of-life care.
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http://dx.doi.org/10.1007/s00406-020-01186-zDOI Listing
September 2020

Comparative study of lung ultrasound and chest computed tomography scan in the assessment of severity of confirmed COVID-19 pneumonia.

Intensive Care Med 2020 09 29;46(9):1707-1713. Epub 2020 Jul 29.

Department of Anesthesiology and Intensive Care Medicine, Hôpital Nord, Assistance Publique Hôpitaux de Marseille, Aix Marseille University, 13015, Marseille, France.

Purpose: The relationship between lung ultrasound (LUS) and chest computed tomography (CT) scans in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pneumonia is not clearly defined. The primary objective of our study was to assess the performance of LUS in determining severity of SARS-CoV-2 pneumonia compared with chest CT scan. Secondary objectives were to test the association between LUS score and location of the patient, use of mechanical ventilation, and the pulse oximetry (SpO)/fractional inspired oxygen (FiO) ratio.

Methods: A multicentre observational study was performed between 15 March and 20 April 2020. Patients in the Emergency Department (ED) or Intensive Care Unit (ICU) with acute dyspnoea who were PCR positive for SARS-CoV-2, and who had LUS and chest CT performed within a 24-h period, were included.

Results: One hundred patients were included. LUS score was significantly associated with pneumonia severity assessed by chest CT and clinical features. The AUC of the ROC curve of the relationship of LUS versus chest CT for the assessment of severe SARS-CoV-2 pneumonia was 0.78 (CI 95% 0.68-0.87; p < 0.0001). A high LUS score was associated with the use of mechanical ventilation, and with a SpO/FiO ratio below 357.

Conclusion: In known SARS-CoV-2 pneumonia patients, the LUS score was predictive of pneumonia severity as assessed by a chest CT scan and clinical features. Within the limitations inherent to our study design, LUS can be used to assess SARS-CoV-2 pneumonia severity.
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http://dx.doi.org/10.1007/s00134-020-06186-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388119PMC
September 2020

End-of-Life Care Among Patients With Bipolar Disorder and Cancer: A Nationwide Cohort Study.

Psychosom Med 2020 09;82(7):722-732

From the Aix-Marseille University, CEReSS-Health Service Research and Quality of Life Center (Fond, Baumstarck, Auquier, Pauly, Bernard, Lancon, Boyer); Department of Medical Information (Fond, Pauly, Orleans, Boyer) and Epidemiology and Health Economics (Fond, Auquier, Boyer), APHM, Marseille; CHU Clermont-Ferrand (Llorca), Clermont-Ferrand, France; and Departments of Psychiatry (Lancon) and Adult Oncology (Salas), APHM, Marseille, France.

Objective: This study aimed to describe end-of-life (EOL) care in individuals with bipolar disorder (BD) who died of cancer compared with mentally healthy individuals.

Methods: This was a nationwide cohort study of all adult individuals who died of cancer in hospitals in France between 2013 and 2016. Outcomes were compared between individuals with BD and mentally healthy individuals in the last month of life including palliative care and high-intensity EOL care (chemotherapy, artificial nutrition, and other interventions). A subanalysis explored differences between patients with BD and patients with schizophrenia.

Results: The study included 2015 individuals with BD and 222,477 mentally healthy controls. Compared with the controls, individuals with BD died 5 years earlier, more often had comorbidities and thoracic cancer, and had fewer metastases, but did not have shorter delays from cancer diagnosis to death. After matching and adjustment for covariates, individuals with BD more often received palliative care in the last 3 days of life (25% versus 13%, p < .001) and less high-intensity care (e.g., chemotherapy 12% versus 15%, p = .004), but more artificial nutrition (6% versus 4.6%, p = .003). Compared with the schizophrenia comparison group, chemotherapy was received more by individuals with BD in the last 14 days of life (12.5% for BD versus 9.4%, p < .001).

Conclusions: Individuals with BD were more likely to receive palliative care and less likely to receive high-intensity EOL care, except for artificial nutrition. These results may not be specific to BD, as no difference was found between patients with BD and schizophrenia except for chemotherapy.
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http://dx.doi.org/10.1097/PSY.0000000000000839DOI Listing
September 2020

Optimal Timing of Intervention in NSTE-ACS Without Pre-Treatment: The EARLY Randomized Trial.

JACC Cardiovasc Interv 2020 04;13(8):907-917

Aix-Marseille Université, Intensive Care Unit, Department of Cardiology, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology, Marseille, France; Centre for CardioVascular and Nutrition Research, INSERM 1263, INRA 1260, Marseille, France. Electronic address:

Objectives: The aim of this study was to compare a delayed and a very early invasive strategy in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) without pre-treatment.

Background: The optimal delay of the invasive strategy in patients with NSTE-ACS remains debated and has never been investigated in patients not pre-treated with P2Y-adenosine diphosphate receptor antagonists.

Methods: A prospective, open-label, randomized controlled trial was conducted. Altogether, 741 patients presenting with intermediate- or high-risk NSTE-ACS intended for an invasive strategy were included. The modified intention-to-treat analysis was composed of 709 patients after 32 withdrew consent. Patients were randomized 1:1 to the delayed invasive group (DG) (n = 363) with coronary angiography (CA) performed 12 to 72 h after randomization or the very early invasive group (EG) (n = 346) with CA within 2 h. No pre-treatment with a loading dose of a P2Y-adenosine diphosphate receptor antagonist was allowed before CA. The primary endpoint was the composite of cardiovascular death and recurrent ischemic events at 1 month, as determined by a blinded adjudication committee.

Results: Most patients had high-risk NSTE-ACS in both groups (93% in the EG vs. 92.5% in the DG). The median time between randomization and CA was 0 h (interquartile range [IQR]: 0 to 1 h) in the EG group and 18 h (IQR: 11 to 23 h) in the DG. The primary endpoint rate was significantly lower in the EG (4.4% vs. 21.3% in the DG; hazard ratio: 0.20; 95% confidence interval: 0.11 to 0.34; p < 0.001), driven by a reduction in recurrent ischemic events (19.8% vs. 2.9%; p < 0.001). No difference was observed for cardiovascular death.

Conclusions: Without pre-treatment, a very early invasive strategy was associated with a significant reduction in ischemic events at the time of percutaneous coronary intervention in patients with intermediate- and high-risk NSTE-ACS. (Early or Delayed Revascularization for Intermediate and High-Risk Non ST-Elevation Acute Coronary Syndromes; NCT02750579).
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http://dx.doi.org/10.1016/j.jcin.2020.01.231DOI Listing
April 2020

Impact of severe polyhandicap cared for at home on French informal caregivers' burden: a cross-sectional study.

BMJ Open 2020 02 2;10(1):e032257. Epub 2020 Feb 2.

Hôpital de La Roche Guyon, Assistance Publique - Hopitaux de Paris, Paris, Île-de-France, France.

Objectives: Polyhandicap (PLH), defined by a combination of profound intellectual impairment and serious motor deficits, is a severe condition with complex disabilities. In France, care of the large majority of PLH individuals is managed in specialised rehabilitation centres or residential facilities, but some of PLH individuals are cared for at home. The aims of this study were to assess the self-perceived burden among informal caregivers of PLH individuals and to identify potential determinants of this burden.

Design: Cross-sectional study (Neuropaediatric Department, Trousseau Hospital, Paris, France).

Settings: PLH children were recruited from a specialised paediatric/neurological department.

Participants: The selection criteria of caregivers were age above 18 years and being the PLH individual's next of kin.

Outcomes Measures: From March 2015 to December 2016, data were collected from the caregivers, including sociodemographical data, health status, psycho-behavioural data (quality of life, mood disorders and coping) and self-perceived burden. In addition, the health status of the PLH individual was collected. Relationships between the burden scores and potential determinants were tested (correlations coefficients, Mann-Whitney tests, generalised estimating equations models).

Results: Eighty-four children were eligible; 77 families returned their questionnaire. The informal caregivers of PLH children experienced a high level of perceived burden (scores ranged from 55±20 to 81±12). Eighty per cent of them had more than 5 hours of daily caregiving and 51% of them had to get up more than twice during the night. The main factors associated with caregiver burden were age, financial issues, health status, daily care and coping strategies. The patients' health status was not associated with caregiver burden.

Conclusions: Some of the caregiver burden determinants might be modifiable. These findings should help healthcare workers and health-decision makers implement specific and appropriate interventions.

Trial Registration Number: NCT02400528.
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http://dx.doi.org/10.1136/bmjopen-2019-032257DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045096PMC
February 2020

Everolimus and Octreotide for Patients with Recurrent Meningioma: Results from the Phase II CEVOREM Trial.

Clin Cancer Res 2020 02 22;26(3):552-557. Epub 2020 Jan 22.

Aix-Marseille Univ, APHM, CNRS, INP, Inst Neurophysiopathol, CHU Timone, Service de Neuro-Oncologie, Marseille, France.

Purpose: Aggressive meningiomas that progress after surgery/radiotherapy represent an unmet medical need. Strong and constant expression of SSTR2A receptors and activation of the Pi3K/Akt/mTOR pathway have been demonstrated in meningiomas. The combination of everolimus, an mTOR inhibitor, and octreotide, a somatostatin agonist, has shown additive antitumor effect . The phase II CEVOREM trial investigated the efficacy of this combination on recurrent meningiomas.

Patients And Methods: Patients with documented recurrent tumor progression ineligible for further surgery/radiotherapy were eligible to receive octreotide (30 mg/d, day 1) and everolimus (10 mg/d, days 1-28). The primary endpoint was the 6-month progression-free survival rate (PFS6). The secondary endpoints were overall survival, response rate, tumor growth rate according to central review, and safety.

Results: A total of 20 patients were enrolled, including 2 with World Health Organization (WHO) grade I tumors, 10 with WHO grade II tumors, and 8 with WHO grade III tumors; furthermore, 4 patients harbored germline mutation. The overall PFS6 was 55% [95% confidence interval (CI), 31.3%-73.5%], and overall 6- and 12-month survival rates were 90% (95% CI, 65.6%-97.4%) and 75% (95% CI, 50.0%-88.7%), respectively. A major decrease (>50%) was observed in the growth rate at 3 months in 78% of tumors. The median tumor growth rate decreased from 16.6%/3 months before inclusion to 0.02%/3 months at 3 months ( < 0.0002) and 0.48%/3 months at 6 months after treatment ( < 0.0003).

Conclusions: The combination of everolimus and octreotide was associated with clinical and radiological activity in aggressive meningiomas and warrants further studies. Decrease in the tumor volume growth rate should be considered a complementary and sensitive endpoint to select potentially effective drugs for recurrent meningiomas.
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http://dx.doi.org/10.1158/1078-0432.CCR-19-2109DOI Listing
February 2020

Recurrent major depressive disorder's impact on end-of-life care of cancer: A nationwide study.

J Affect Disord 2020 02 5;263:326-335. Epub 2019 Dec 5.

Aix-Marseille Univ., CEReSS - Health Service Research and Quality of Life Center, Marseille, France; Department of Medical Information, APHM, Marseille, France; Department of Epidemiology and Health Economics, APHM, Marseille, France.

Objective: We still don't know if recurrent major depressive disorder (RMDD) may impact the quality of the end-of-life (EOL) cancer care in France. To tackle this knowledge gap, we explored EOL care in RMDD subjects who died from cancer compared to subjects without psychiatric disorder in a 4-year nationwide cohort study.

Design: Nationwide cohort study.

Setting: National hospital database, France.

Participants: All patients aged ≥15 years who died from cancer in hospital: 4070 RMDD subjects and 222,477 controls, 2013-2016, France.

Main Outcome Measures: Palliative care in the last 31 days of life and high-intensity EOL care including chemotherapy in the last 14 days of life, artificial nutrition, tracheal intubation, mechanical ventilation, gastrostomy, cardiopulmonary resuscitation, dialysis, transfusion, surgery, endoscopy, imaging, intensive care unit and emergency department admission in the last 31 days of life. Multivariate generalized mixed models with log-normal distribution was used to compare RMDD subjects and controls.

Results: Compared to the controls, the RMDD subjects died 3 years younger, had more comorbidities, more thoracic cancers, less metastases and longer time from cancer diagnosis to death. After matching and adjustment, subjects with RMDD were found to receive more palliative care and less high-intensity EOL care, had fewer iterative admissions to acute care unit, and died less often in the intensive care unit and emergency department.

Conclusions: RMDD subjects were more likely to receive palliative care associated with less high-intensity EOL care. Yet the interpretation may be discussed, resulting from either patients'/families' wishes or difficulties for providers in offering personalized care to RMDD.
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http://dx.doi.org/10.1016/j.jad.2019.12.003DOI Listing
February 2020

Circadian disruption of core body temperature in trauma patients: a single-center retrospective observational study.

J Intensive Care 2020 6;8. Epub 2020 Jan 6.

Service d'Anesthésie et de Réanimation, APHM, Hôpital Nord, Aix Marseille Université, Chemin des Bourrely, 13915 Marseille, France.

Background: Circadian clock alterations were poorly reported in trauma patients, although they have a critical role in human physiology. Core body temperature is a clinical variable regulated by the circadian clock. Our objective was to identify the circadian temperature disruption in trauma patients and to determine whether these disruptions were associated with the 28-day mortality rate.

Methods: A retrospective and observational single-center cohort study was conducted. All adult severe trauma patients admitted to the intensive care unit of Aix Marseille University, North Hospital, from November 2013 to February 2018, were evaluated. The variations of core body temperature for each patient were analyzed between days 2 and 3 after intensive care unit admission. Core body temperature variations were defined by three parameters: mesor, amplitude, and period. A logistic regression model was used to determine the variables influencing these three parameters. A survival analysis was performed assessing the association between core body temperature rhythm disruption and 28-day mortality rate. A post hoc subgroup analysis focused on the patients with head trauma.

Results: Among the 1584 screened patients, 248 were included in this study. The period differed from 24 h in 177 (71%) patients. The mesor value (°C) was associated with body mass index and ketamine use. Amplitude (°C) was associated with ketamine use only. The 28-day mortality rate was 18%. For all trauma patients, age, body mass index, intracranial hypertension, and amplitude were independent risk factors. The patients with a mesor value < 36.9 °C ( < 0.001) and an amplitude > 0.6 °C ( < 0.001) had a higher 28-day mortality rate. Among the patients with head trauma, mesor and amplitude were identified as independent risk factors (HR = 0.40, 95% CI [0.23-0.70],  = 0.001 and HR = 4.73, 95% CI [1.38-16.22],  = 0.01).

Conclusions: Our results highlight an association between core body temperature circadian alteration and 28-day mortality rate. This association was more pronounced in the head trauma patients than in the non-head trauma patients. Further studies are needed to show a causal link and consider possible interventions.
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http://dx.doi.org/10.1186/s40560-019-0425-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6945723PMC
January 2020

Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch-anal anastomosis? A multicenter randomized trial of the GETAID Chirurgie group (IDEAL trial): rationale and design (NCT03872271).

BMC Surg 2019 Dec 12;19(1):192. Epub 2019 Dec 12.

Department of Digestive Surgery, AP-HP, Hôpital Saint Antoine, Sorbonne Université, F-75012, Paris, France.

Background: There is no quality evidence of the benefit of defunctioning ileostomy (DI) in ileal pouch-anal anastomoses (IPAAs) performed for inflammatory bowel disease (IBD), but most surgical teams currently resort to DI. In the case of a staged procedure with subtotal colectomy first, completion proctectomy with IPAA is performed for healthy patients, namely, after nutritional support, inflammation reduction and immunosuppressive agent weaning. Therefore, the aim of this trial is to assess the need for systematic DI after completion proctectomy and IPAA for IBD.

Methods/design: This is a multicenter randomized open trial comparing completion proctectomy and IPAA without (experimental) or with (control) DI in patients presenting with ulcerative colitis or indeterminate colitis. Crohn's disease patients will not be included. The design is a superiority trial. The main objective is to compare the 6-month global postoperative morbidity, encompassing both surgical and medical complications, between the two groups. The morbidity of DI closure will be included, as appropriate. The sample size calculation is based on the hypothesis that the overall 6-month morbidity rate is 30% in the case of no stoma creation (i.e., experimental group) vs. 55% otherwise (control group). With the alpha risk and power are fixed to 0.05 and 0.80, respectively, and considering a dropout rate of 10%, the objective is set to 194 patients. The secondary objectives are to compare both strategies in terms of morbi-mortality at 6 months and functional results as well as quality of life at 12 months, namely, the 6-month major morbidity and unplanned reoperation rates, 6-month anastomotic leakage rate, 6-month mortality, length of hospital stay, 6-month unplanned readmission rate, quality of life assessed 3 and 12 months from continuity restoration (i.e., either IPAA or stoma closure), functional results assessed 3 and 12 months from continuity restoration, 12-month pouch results, 12-month cost-utility analysis, and 12-month global morbidity.

Discussion: The IDEAL trial is a nationwide multicenter study that will help choose the optimal strategy between DI and no ileostomy in completion proctectomy with IPAA for IBD.

Trial Registration: ClinicalTrial.gov: NCT03872271, date of registration March 13th, 2019.
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http://dx.doi.org/10.1186/s12893-019-0657-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6909507PMC
December 2019

Use of artificial nutrition near the end of life: Results from a French national population-based study of hospitalized cancer patients.

Cancer Med 2020 01 26;9(2):530-540. Epub 2019 Nov 26.

Department of Adult Oncology, APHM, Marseille, France.

Background: The use of artificial nutrition, defined as a medical treatment that allows a non-oral mechanical feeding, for cancer patients with limited life expectancy is deemed nonbeneficial. High-quality evidence about the use of artificial nutrition near the end of life is lacking. This study aimed (a) to quantify the use of artificial nutrition near the end-of-life, and (b) to identify the factors associated with the use of artificial nutrition.

Methods: This was a retrospective cohort study of decedents based on data from the French national hospital database. The study population included adult cancer patients who died in hospitals in France between 2013 and 2016 and defined to be in a palliative condition. Use of artificial nutrition during the last 7 days before death was the primary endpoint.

Results: A total of 398 822 patients were included. The median duration of the last hospital stay was 10 (interquartile range, 4-21) days. The artificial nutrition was used for 11 723 (2.9%) during the last 7 days before death. Being a man, younger, having digestive cancers, metastasis, comorbidities, malnutrition, absence of dementia, and palliative care use were the main factors associated to the use of artificial nutrition.

Conclusion: This study indicates that the use of artificial nutrition near the end of life is in keeping with current clinical guidelines. The identification of factors associated with the use of artificial nutrition, such as cancer localization, presence of comorbidities or specific symptoms, may help to better manage its use.
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http://dx.doi.org/10.1002/cam4.2731DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6970047PMC
January 2020

End-of-life care among patients with schizophrenia and cancer: a population-based cohort study from the French national hospital database.

Lancet Public Health 2019 11;4(11):e583-e591

Centre d'Eacute;tude et de Recherche sur les Services de Santé et la Qualité de Vie, Aix-Marseille University, Marseille, France; Department of Medical Information, Assistance Publique-Hôpitaux de Marseille, Marseille, France; Department of Epidemiology and Health Economics, Assistance Publique-Hôpitaux de Marseille, Marseille, France.

Background: Patients with schizophrenia represent a vulnerable, underserved, and undertreated population who have been neglected in health disparities work. Understanding of end-of-life care in patients with schizophrenia and cancer is poor. We aimed to establish whether end-of-life care delivered to patients with schizophrenia and cancer differed from that delivered to patients with cancer who do not have diagnosed mental illness.

Methods: We did a population-based cohort study of all patients older than 15 years who had a diagnosis of advanced cancer and who died in hospital in France between Jan 1, 2013, and Dec 31, 2016. We divided this population into cases (ie, patients with schizophrenia) and controls (ie, patients without a diagnosis of mental illness) and compared access to palliative care and indicators of high-intensity end-of-life care between groups. In addition to unmatched analyses, we also did matched analyses (matched in terms of age at death, sex, and site of primary cancer) between patients with schizophrenia and matched controls (1:4). Multivariable generalised linear models were done with adjustment for social deprivation, year of death, time from cancer diagnosis to death, metastases, comorbidity, and hospital type (ie, specialist cancer centre vs non-specialist centre).

Findings: The main analysis included 2481 patients with schizophrenia and 222 477 controls. The matched analyses included 2477 patients with schizophrenia and 9896 controls. Patients with schizophrenia were more likely to receive palliative care in the last 31 days of life (adjusted odds ratio 1·61 [95% CI 1·45-1·80]; p<0·0001) and less likely to receive high-intensity end-of-life care-such as chemotherapy and surgery-than were matched controls without a diagnosis of mental illness. Patients with schizophrenia were also more likely to die younger, had a shorter duration between cancer diagnosis and death, and were more likely to have thoracic cancers and comorbidities than were controls.

Interpretation: Our findings suggest the existence of disparities in health and health care between patients with schizophrenia and patients without a diagnosis of mental illness. These findings underscore the need for better understanding of health inequalities so that effective interventions can be developed for this vulnerable population.

Funding: Assistance Publique des Hôpitaux de Marseille and Aix-Marseille University.
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http://dx.doi.org/10.1016/S2468-2667(19)30187-2DOI Listing
November 2019
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